BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED CROSS TESTING CHAGAS DISEASE TEST

    MDR report key: 5840021 · Received July 25, 2016

    Report

    Report Number
    MW5063780
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    July 25, 2016
    Report Date
    July 25, 2016
    Manufacturer
    UNK
    Product Code
    OHQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WENT TO DONATE BLOOD W/(B)(6). TOLD I WAS DEFERRED UNTIL 2289 FORCHAGUS DISEASE. FOUND THAT I HAD A FALSE POSITIVE AND COULD NEVER DONATE AGAIN WITH NO APPEAL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474233 RED CROSS TESTING CHAGAS DISEASE TEST RED CROSS TESTING CHAGAS DISEASE TEST OHQ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention